Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Last updated: May 4, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

AZD5148

Placebo

Clinical Study ID

NCT07285213
D8820C00003
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent.

Participants with a qualifying C. difficile infection episode at the time of providing informed consent defined by:

  • Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformedstool sample collected during this episode, and

  • Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned durationof at least 10 and at most 25 days at time of IMP administration.

Note: Diarrhea is not required to be present on the day of investigational medicinal product (IMP) administration.

Body weight ≥ 40 kg

Exclusion

Exclusion Criteria:

History of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease, microscopic colitis).

Participant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)

Planned surgery for C. difficile infection within 24 hours of enrollment

Current toxic megacolon and/or small bowel ileus

Any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).

Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)

Due to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode

Treatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, or planned administration during the 180 days after IMP administration

Treatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: AZD5148
Phase: 2
Study Start date:
December 10, 2025
Estimated Completion Date:
January 18, 2028

Study Description

Approximately 230 participants will be enrolled and randomized 1:1 to receive a single dose of either AZD5148 or placebo (normal saline). Route of administration (intramuscular or intravenous push) will be according to the Investigator's choice. Stratification will be based on geographical region.

Study details include:

  • Up to 2 site visits for confirmation of eligibility and dose administration, including stool sample collection;

  • Up to 7 planned visits;

  • Contacts initiated by site staff -weekly, later monthly follow up;

  • Electronic diary completion.

Connect with a study center

  • Research Site

    Camperdown, 2050
    Australia

    Active - Recruiting

  • Research Site

    Camperdown 2172563, 2050
    Australia

    Site Not Available

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Clayton 2171400, 3168
    Australia

    Site Not Available

  • Research Site

    Herston, 4029
    Australia

    Active - Recruiting

  • Research Site

    Herston 6931014, 4029
    Australia

    Site Not Available

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Melbourne 2158177, 3000
    Australia

    Site Not Available

  • Research Site

    South Brisbane, 4101
    Australia

    Active - Recruiting

  • Research Site

    South Brisbane 2207259, 4101
    Australia

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Research Site

    Edmonton 5946768, Alberta 5883102 T6G 2X8
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Research Site

    Victoria, British Columbia V8T 5G4
    Canada

    Site Not Available

  • Research Site

    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
    Canada

    Site Not Available

  • Research Site

    Victoria 6174041, British Columbia 5909050 V8T 5G4
    Canada

    Site Not Available

  • Research Site

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • Research Site

    Halifax 6324729, Nova Scotia 6091530 B3K 6R8
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Research Site

    London, Ontario N6A 5A5
    Canada

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  • Research Site

    Hamilton 5969782, Ontario 6093943 L8N 4A6
    Canada

    Site Not Available

  • Research Site

    London 6058560, Ontario 6093943 N6C 2R5
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4A 3S5
    Canada

    Active - Recruiting

  • Research Site

    Québec, Quebec G1V 4T3
    Canada

    Active - Recruiting

  • Research Site

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H4A 3S5
    Canada

    Site Not Available

  • Research Site

    Québec 6325494, Quebec 6115047 G1V 4T3
    Canada

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  • Research Site

    Sherbrooke 6146143, Quebec 6115047 J1H 5N4
    Canada

    Site Not Available

  • Research Site

    Aalborg, DK9000
    Denmark

    Site Not Available

  • Research Site

    Aalborg 2624886, DK9000
    Denmark

    Site Not Available

  • Research Site

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Research Site

    Aarhus N 11746890, 8200
    Denmark

    Site Not Available

  • Research Site

    Hvidovre, 2650
    Denmark

    Active - Recruiting

  • Research Site

    Hvidovre 2619528, 2650
    Denmark

    Site Not Available

  • Research Site

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Research Site

    København Ø 11746747, 2100
    Denmark

    Site Not Available

  • Research Site

    Odense C, 5000
    Denmark

    Active - Recruiting

  • Research Site

    Odense C 11746507, 5000
    Denmark

    Site Not Available

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    Lyon, 69317
    France

    Active - Recruiting

  • Research Site

    Lyon 2996944, 69317
    France

    Site Not Available

  • Research Site

    Montpellier, 34295
    France

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  • Research Site

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Research Site

    Nantes, 44093
    France

    Active - Recruiting

  • Research Site

    Nantes 2990969, 44093
    France

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    Nîmes, 30029
    France

    Active - Recruiting

  • Research Site

    Nîmes 2990363, 30029
    France

    Site Not Available

  • Research Site

    Paris, 75475
    France

    Active - Recruiting

  • Research Site

    Paris 2988507, 75014
    France

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  • Research Site

    Tours, 37044
    France

    Active - Recruiting

  • Research Site

    Tours 2972191, 37044
    France

    Site Not Available

  • Research Site

    Augsburg, 86156
    Germany

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  • Research Site

    Augsburg 2954172, 86156
    Germany

    Site Not Available

  • Research Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Research Site

    Berlin 2950159, 13353
    Germany

    Site Not Available

  • Research Site

    Cologne, 50937
    Germany

    Active - Recruiting

  • Research Site

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Research Site

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt 2925536, 60590
    Germany

    Site Not Available

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    Hamburg, 20246
    Germany

    Active - Recruiting

  • Research Site

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Research Site

    Jena, 07747
    Germany

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  • Research Site

    Jena 2895044, 07747
    Germany

    Site Not Available

  • Research Site

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Research Site

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • Research Site

    München, 81675
    Germany

    Active - Recruiting

  • Research Site

    München 2867711, 81675
    Germany

    Site Not Available

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    Athens, 11527
    Greece

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  • Research Site

    Athens 264371, 12462
    Greece

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    Heraklion, 71500
    Greece

    Site Not Available

  • Research Site

    Heraklion 261745, 71500
    Greece

    Site Not Available

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    Ioannina, 45500
    Greece

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  • Research Site

    Ioannina 261779, 45500
    Greece

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  • Research Site

    Thessaloniki, 57010
    Greece

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  • Research Site

    Thessaloniki 734077, 57010
    Greece

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    Budapest, 1082
    Hungary

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  • Research Site

    Budapest 3054643, 1082
    Hungary

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    Debrecen, 4031
    Hungary

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  • Research Site

    Debrecen 721472, 4031
    Hungary

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    Eger, 3300
    Hungary

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  • Research Site

    Eger 721239, 3300
    Hungary

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    Kistarcsa, 2143
    Hungary

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  • Research Site

    Kistarcsa 3050290, 2143
    Hungary

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    Pécs, 7624
    Hungary

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    Pécs 3046526, 7624
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    Modena, 41124
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    Modena 3173331, 41124
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    Naples, 80131
    Italy

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    Napoli, 80131
    Italy

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    Napoli 9031661, 80131
    Italy

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    Palermo, 90127
    Italy

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  • Research Site

    Palermo 2523920, 90127
    Italy

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    Pisa, 56124
    Italy

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  • Research Site

    Pisa 3170647, 56124
    Italy

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    Roma, 00161
    Italy

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    Roma 8957247, 00161
    Italy

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    Varese, 21100
    Italy

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    Varese 3164699, 21100
    Italy

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    Kochi, 780-8522
    Japan

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  • Research Site

    Kochi 1859146, 780-8522
    Japan

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    Kumamoto, 861-8520
    Japan

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    Kumamoto 1858421, 861-8520
    Japan

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    Meguro-ku, 153-0051
    Japan

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    Nagasaki, 852-8501
    Japan

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    Nagasaki 1856177, 852-8501
    Japan

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    Shimonoseki-shi, 750-8520
    Japan

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  • Research Site

    Yaizu-shi, 425-8505
    Japan

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  • Research Site

    Lublin, 20-081
    Poland

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  • Research Site

    Lublin 765876, 20-081
    Poland

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    Warsaw, 04-141
    Poland

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  • Research Site

    Warsaw 756135, 04-141
    Poland

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    Alicante, 03010
    Spain

    Active - Recruiting

  • Research Site

    Alicante 2521978, 03010
    Spain

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  • Research Site

    Badalona, 08916
    Spain

    Active - Recruiting

  • Research Site

    Badalona 3129028, 08916
    Spain

    Site Not Available

  • Research Site

    Madrid, 28046
    Spain

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  • Research Site

    Madrid 3117735, 28034
    Spain

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    Majadahonda, 28220
    Spain

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  • Research Site

    Majadahonda 3117667, 28220
    Spain

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    Seville, 41009
    Spain

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    Seville 2510911, 41009
    Spain

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    Helsingborg, 25187
    Sweden

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    Helsingborg 2706767, 25187
    Sweden

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    Lund, 22185
    Sweden

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  • Research Site

    Lund 2693678, 22185
    Sweden

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  • Research Site

    Malmo, 20502
    Sweden

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  • Research Site

    Malmo 2692969, 20502
    Sweden

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  • Research Site

    Malmö, 20502
    Sweden

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    Västerås, 72189
    Sweden

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  • Research Site

    Västerås 2664454, 72189
    Sweden

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  • Research Site

    Birmingham, B15 2TH
    United Kingdom

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  • Research Site

    Birmingham 2655603, B15 2TH
    United Kingdom

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    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

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    Phoenix, Arizona 85032
    United States

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  • Research Site

    Phoenix 5308655, Arizona 5551752 85032
    United States

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    Chula Vista, California 91911
    United States

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    Sacramento, California 95817
    United States

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    Torrance, California 90502
    United States

    Active - Recruiting

  • Research Site

    Chula Vista 5336899, California 5332921 91911
    United States

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    Sacramento 5389489, California 5332921 95817
    United States

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  • Research Site

    Torrance 5403022, California 5332921 90502
    United States

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    Hamden, Connecticut 06518
    United States

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  • Research Site

    Hamden 4835654, Connecticut 4831725 06518
    United States

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    Gainesville, Florida 32605
    United States

    Active - Recruiting

  • Research Site

    Hialeah, Florida 33016
    United States

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  • Research Site

    Homestead, Florida 33033
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

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    Miami Lakes, Florida 33014
    United States

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  • Research Site

    Miramar, Florida 33027
    United States

    Active - Recruiting

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    Port Orange, Florida 32127
    United States

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  • Research Site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

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    Tampa, Florida 33607
    United States

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    Gainesville 4156404, Florida 4155751 32605
    United States

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  • Research Site

    Homestead 4159050, Florida 4155751 33033
    United States

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  • Research Site

    Jacksonville 4160021, Florida 4155751 32256
    United States

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    Miami Lakes 4164186, Florida 4155751 33014
    United States

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    Miramar 4164601, Florida 4155751 33027
    United States

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    Port Orange 4169156, Florida 4155751 32127
    United States

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    Tamarac 4174738, Florida 4155751 33321
    United States

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    Tampa 4174757, Florida 4155751 33607
    United States

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    Athens, Georgia 30606
    United States

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    Atlanta, Georgia 30322
    United States

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    Athens 4180386, Georgia 4197000 30606
    United States

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    Atlanta 4180439, Georgia 4197000 30322
    United States

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    Idaho Falls, Idaho 83404
    United States

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    Idaho Falls 5596475, Idaho 5596512 83404
    United States

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    Burr Ridge, Illinois 60527
    United States

    Active - Recruiting

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    Burr Ridge 4886090, Illinois 4896861 60527
    United States

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    Lexington, Kentucky 40509
    United States

    Active - Recruiting

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    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Site

    Lexington 4297983, Kentucky 6254925 40509
    United States

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    Louisville 4299276, Kentucky 6254925 40202
    United States

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    New Orleans, Louisiana 70121
    United States

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    New Orleans 4335045, Louisiana 4331987 70121
    United States

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    Glen Burnie, Maryland 21061
    United States

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  • Research Site

    Potomac, Maryland 20854
    United States

    Active - Recruiting

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    Glen Burnie 4356188, Maryland 4361885 21061
    United States

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    Potomac 4366001, Maryland 4361885 20854
    United States

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  • Research Site

    Boston, Massachusetts 02115
    United States

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    Boston 4930956, Massachusetts 6254926 02114
    United States

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    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

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  • Research Site

    Royal Oak 5007804, Michigan 5001836 48073
    United States

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  • Research Site

    Columbia, Missouri 65212
    United States

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  • Research Site

    St Louis, Missouri 63130
    United States

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  • Research Site

    Columbia 4381982, Missouri 4398678 65212
    United States

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  • Research Site

    St Louis 4407066, Missouri 4398678 63130
    United States

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  • Research Site

    Union City, New Jersey 07087
    United States

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  • Research Site

    Hartsdale, New York 10530
    United States

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  • Research Site

    Inwood, New York 11096
    United States

    Site Not Available

  • Research Site

    The Bronx, New York 10451
    United States

    Active - Recruiting

  • Research Site

    Hartsdale 5120141, New York 5128638 10530
    United States

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  • Research Site

    Inwood 5122280, New York 5128638 11096
    United States

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    The Bronx 5110266, New York 5128638 10451
    United States

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    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Research Site

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Research Site

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Site Not Available

  • Research Site

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15237
    United States

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  • Research Site

    Johnson City, Tennessee 37614
    United States

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  • Research Site

    Johnson City 4633419, Tennessee 4662168 37614
    United States

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    Charlottesville, Virginia 22903
    United States

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    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Research Site

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Research Site

    Charlottesville 4752031, Virginia 6254928 22903
    United States

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    Lynchburg 4771075, Virginia 6254928 24501
    United States

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  • Research Site

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Site Not Available

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    Seattle, Washington 98109
    United States

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  • Research Site

    Seattle 5809844, Washington 5815135 98109
    United States

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    Madison, Wisconsin 53705
    United States

    Site Not Available

  • Research Site

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Site Not Available

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